Effect of Laparoscopic Splenectomy on Renal Function in Cirrhotic Patients With Hypersplenism (2-Year Follow-Up)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNorthern Jiangsu People's Hospital

About this trial

Patients with liver cirrhosis often have impaired or at-risk kidney function due to the close link between liver and kidney (hepatorenal syndrome). Laparoscopic splenectomy is commonly used to treat splenomegaly and hypersplenism in these patients, but its impact on kidney function over 2 years is unclear. This study will follow patients undergoing laparoscopic splenectomy to measure changes in kidney function before and after surgery, identify risk factors for kidney damage and whether laparoscopic splenectomy can improve kidney function in the long term, and help improve care to protect kidney function in cirrhotic patients .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of liver cirrhosis (clinical, laboratory, imaging)

Splenomegaly and hypersplenism

No history of portal hypertension bleeding (esophageal and gastric variceal bleeding )

Age 18-80 years, male or female

Disqualifiers

Child-Pugh Class C liver cirrhosis

Primary renal diseases (glomerulonephritis, polycystic kidney disease, chronic pyelonephritis, etc.)

Previous abdominal surgery precluding safe laparoscopic splenectomy

Severe cardiac, pulmonary, cerebrovascular dysfunction; malignant tumors; primary hematological disorders

Trial population

Prospective, single-center, observational cohort study with a total duration of 24 months (2 years). Patients with cirrhosis, splenomegaly and hypersplenism scheduled for elective laparoscopic splenectomy will be enrolled and followed for 2 years to assess renal function dynamics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Serum creatinine (Scr) level

Change in serum creatinine (Scr) level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
2

Glomerular filtration rate (eGFR)

Change in estimated glomerular filtration rate (eGFR) For females: If serum creatinine (Scr) ≤ 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-0.241) × (0.9938)\^Age; If Scr \> 0.7 mg/dL: eGFR = 142 × (Scr/0.7)\^(-1.200) × (0.9938)\^Age. For males: If Scr ≤ 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-0.302) × (0.9938)\^Age; If Scr \> 0.9 mg/dL: eGFR = 142 × (Scr/0.9)\^(-1.200) × (0.9938)\^Age. Note: Results are in mL/min/1.73 m². Age is in years.

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24

Secondary outcomes

1

BUN and UA level

Changes in BUN and UA level

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
2

Urine albumin-to-creatinine ratio (UACR)

Changes in Urine albumin-to-creatinine ratio \[UACR (mg/g) = Urine albumin concentration (mg/L) ÷ Urine creatinine concentration (g/L)\]

Time frame
at preoperative baseline, postoperative month 1, month 3, month 6, month 12, month 18, month 24
3

Intraoperative variables

operation time, intraoperative blood loss, fluid infusion

Time frame
During the procedure of operation
4

Postoperative complications

bleeding, infection, hepatic encephalopathy, ascites

Time frame
at preoperative baseline, postoperative day 1, day 3, day 7, month 1, month 3, month 6, month 12, month 18, month 24

Other outcomes

Sponsors and contacts

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